cath lab studies


CATH LAB STUDIES: Contracted Research, Clnical Trials, Actively recruiting


Re-Dual PCI

Study in non valvular AF patients undergoing PCI
Principal Investigator: Dr. John Ducas
Co-Investigators: Dr. Malek Kass, Dr. Kunal Minhas,
Dr. Amir Ravandi, Dr. Minh Vo, Dr. Basem Elbarouni, Dr. Olga Toleva





Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385


COMPLETE

A randomized, comparative effectiveness study of complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction

Site Investigator: Dr. John Ducas
Co-investigators: Dr. Kunal Minhas ,Dr. Malek Kass, Dr. Amir Ravandi,
Dr. Olga Toleva, Dr Minh Vo, Dr. Basem Elbarouni
Co-ordinating Centre: PHRI

Objective:
To determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel revascularization involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions is superior to a strategy of culprit lesion only revascularization in reducing the composite outcome of CV death or new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.

Inclusion Criteria:
1. Within 72 hours after successful PCI* (preferably using a drug eluting stent) to the culprit lesion for STEMI.
* PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after fibrinolysis
2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to PCI and has:
? 70% diameter stenosis (visual estimation) or
? 50% diameter stenosis (visual estimation) with fractional flow reserve
(FFR) ? 0.80

Exclusion Criteria:
1. Planned revascularization of non-culprit lesion
2. Planned surgical revascularization
3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
4. Any factor precluding 5 year follow-up
5. Prior CABG Surgery

Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385


SAFARI - STEMI

The SAfety and efficacy of Femoral Access versus RadIal access for Primary PCI in STEMI
Site Investigator: Dr. Malek Kass

Co-investigators: Dr. Kunal Minhas , Dr. John Ducas, Dr. Amir Ravandi,
Dr. Olga Toleva, Dr Minh Vo, Dr. Basem Elbarouni

Objective
The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing PPCI. The trial will include the use of Bivalirudin or unfractionated heparin (UFH) as the anticoagulant during PCI and guideline recommended dual antiplatelet therapy and will encourage the use of vascular closing devices. The trial will also compare delays to reperfusion between the two strategies. In view of recent publications, there is now a need for a large randomized trial using contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in PPCI.

Inclusion
1. Ischemic chest discomfort of 30 minutes duration,
AND
2. Onset of chest pain 12 hrs prior to entry into the study,
AND
3. ST segment elevation of > 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old

Exclusion
o Active bleeding
o Inadequate vascular access from the femoral
o Abnormal Allen's test precluding either right or left radial approach
o PCI within the last 30 days
o Fibrinolytic agents within the last 7 days
o Warfarin, dabigatran or other oral anticoagulant within the last 7 days
o Known coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3)
o Allergy to aspirin
o Participation in a study with another investigational device or drug
o Known severe renal impairment (creatinine >200 mol/L)
o Known severe contrast (dye) allergy
o Prior coronary artery bypass surgery
o Inability to provide informed consent

Odyssey
COMPOUND: ALIROCUMAB (SAR236553/REGN727) STUDY No:EFC11570

Co-ordinating Centre: Duke

Objective
The primary objective of this study is to compare the effect of alirocumab with placebo on the occurrence of the composite endpoint :
- coronary heart disease (CHD) death,
- non-fatal myocardial infarction (MI)
- fatal and non-fatal ischemic stroke
- unstable angina requiring hospitalization
in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with an LMT regimen that is statin-intensive (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins and optimized for long-term chronic use with other non-statin LMT(s) at investigator's discretion.

Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385


A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of Evolocumab
Site Investigator: Dr. John Ducas

Co-investigators: Dr. Kunal Minhas, Dr. Malek Kass, Dr. Minh Vo
Dr. Amir Ravandi, Dr. Olga Toleva, Dr. Basem Elbarouni

Primary Objective:
To characterize the safety and tolerability of long-term administration of evolocumab in subjects with known coronary artery disease and hypercholesterolemia

Inclusion
Subjects will be eligible for the study if they:
1. Completed study 20120153
* Did not discontinue evolocumab

Exclusion
o Female subject of reproductive potential not willing to inform her sexual partner of her participation in the clinical study and to use an acceptable method(s) of birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab. Female subjects who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, bilateral tubal ligation, or who are postmenopausal are not required to use contraception.
o Subject is pregnant or breast feeding, or planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
o Unreliability as a study participant based on the investigator's (or designee's) knowledge of the subject (eg, inability or unwillingness to adhere to the protocol)
o Discontinued IP in the parent study 20120153
o Have an unstable medical condition, in the judgment of the investigator
o Subject's medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy during the first 12 weeks of study participation
o Known sensitivity to any of the products to be administered during dosing
o Currently enrolled in another investigational device or drug study (excluding evolocumab parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385


AEGIS-1

A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction
Site Investigator: Dr. Minh Vo
Sponsor: CSL Bering
Co-investigators: Dr. John Ducas, Dr. Amir Ravandi, Dr. Kunal Minhas ,
Dr. Malek Kass, Dr. Basem Elbarouni, Dr. Olga Toleva

Objective: investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

Inclusion Criteria:
¨ Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last week.
Exclusion Criteria:
¨ Ongoing hemodynamic instability
¨ Evidence of hepatobiliary disease
¨ Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis
¨ Evidence of unstable renal function
¨ History of acute kidney injury after previous exposure to an intravenous contrast agent.
¨ Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
¨ Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study

Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385

CMX-2043-2aK (CARIN) study

A Prospective, Comparative, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Phase 2a Study of the Safety and Efficacy of CMX-2043 for Periprocedural Injury Protection in Subjects Undergoing Coronary Angiography at Risk of Radio-contrast Induced Nephropathy (CARIN)

Site Investigator: Dr. John Ducas
Co-investigators: Dr. Kunal Minhas , Dr. Malek Kass, Dr. Basem Elbarouni,
Dr. Amir Ravandi, Dr. Olga Toleva, Dr Minh Vo

Objective:
To assess the efficacy of CMX-2043 for the prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS) or non-ACS patients undergoing a high risk elective coronary angiography, but excluding ST-elevation myocardial infarction (STEMI) patients.

Inclusion Criteria:
1. Male or female subjects at least 18 years of age.
2. Subjects undergoing coronary angiography with a high probability of going on to PCI.
3. Subjects must meet one of the following criteria:
a. acute coronary syndrome (excluding STEMI).
b. undergoing a planned complex PCI (in essence, a planned PCI where more than 75 mL of contrast dye will likely be used).
c. undergoing an urgent coronary angiography (scheduled within 24 hours) following a failed stress test.
d. two or more abnormal ischemic regions identified by stress test.
e. an eGFR between 15.0 - 45.0 mL/min as determined by the MDRD equation and diabetes mellitus who are undergoing elective coronary angiography.
4. Subjects must meet either one of the following criteria:
a. An eGFR between 15.0 - 45.0 mL/min as determined by the MDRD equation
b. An eGFR between 45.1 - 60.0 mL/min as determined by the MDRD equation and at least one of the following:
i. Over 75 years of age
ii. Diabetes mellitus
iii. Ejection fraction less than 40%
iv. Hypotension
v. Congestive heart failure (NYHA stage II or higher)
vi. Anemia (hemoglobin </=10 g/dL at screening)
5. Female subjects must also meet any one of the following criteria:
a. Surgically sterile with bilateral tubal ligation or hysterectomy
b. Post-menopausal for at least one year
c. If of child-bearing potential, practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device or abstinence.
6. Subjects free of non-cardiac acute injuries or illnesses that, in the opinion of the investigator, could put the subject at risk or obscure the interpretation of results.
7. Subjects willing to undergo pre-and post-study blood and urine collection, physical exams and laboratory investigations.
8. Subjects willing to provide signed written informed consent form.

Exclusion Criteria:
1. Subjects undergoing elective coronary angiography for stable angina when the probability of going on to PCI and the probability of acute kidney injury are low.
2. Subjects with end-stage renal disease (i.e., eGFR < 15).
3. Subjects with ST-elevation myocardial infarction (STEMI)
4. Subjects who experienced cardiac arrest associated with the current admission which required chest compressions or cardiopulmonary resuscitation.
5. Subjects who experienced a life threatening arrhythmia associated with the current admission such as ventricular fibrillation or ventricular tachycardia.
6. Subjects who weigh over 125.0 kg.
7. Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests which in the investigators opinion will interfere with the study conduct.
8. Subjects with a history of chronic liver disease or known to have current ALT elevations >/= 2x upper limit of normal or total bilirubin (TB) > 1.5x upper limit of normal or a known history of hepatitis B or C.
9. Subjects with non-cardiac acute illness or injuries in which the investigator considers will increase the risk to the subject or to the study's success or which will obscure the interpretation of the results.
10. Subjects who are currently enrolled or who have participated in a clinical study within 30 days of screening or within 5 half-lives of another study drug, whichever is longer.

Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385


The TOSCA-5 Study

Total Occlusion Study In Coronary Arteries-5
Principal Investigator: Dr. Minh Vo
Co-Investigator: Dr. John Ducas & Dr. Basem Elbarouni
Sponsor Matrizyme Pharma

Primary Objective
The primary objective of the trial is to obtain an estimate of the anterograde PCI success rate for patients with a target CTO that has failed a PCI attempt in each treatment group and to explore safety and tolerability in these patients.

Screening Inclusion Criteria
A patient will be eligible for the study if s/he meets all of the following criteria:
1. Patient has provided signed and dated informed consent in accordance with required regulations.
2. Patient is male or female <18 years of age.
3. If patient is a female of childbearing potential, patient is willing to utilize contraception from Screening through the duration of the study.
4. The patient has a clinically driven, planned PCI of the target CTO, in a major epicardial coronary artery, without planned revascularization of other coronary stenosis/stenoses in major epicardial segments.
5. Target CTO must be ? 3 calendar months old by either:
a. Proven Chronicity: Angiographic documentation (conventional or coronary) of the target CTO 3 or more calendar months prior to Screening or
b. Assumed Chronicity: Identification of the target occlusion has occurred in the setting of chronic ischemic heart disease, with no known or suspected acute coronary syndrome (ACS) within 3 months.
6. The patient is receiving a course of optimal anti-ischemic medical therapy (at least 2 anti-anginal agents or the maximum tolerated anti-anginal therapy). Medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or calcium antagonist) where appropriate.

Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385

Contracted Research, Actively Recruiting, Cohort/Registry

Canadian Spontaneous Coronary Artery Dissection (SCAD) Cohort Study

Principal Investigator: Dr. Jacqueline Saw - Vancouver General Hospital, Vancouver, BC

Site Investigator: Dr. Kunal Minhas

Co-investigators: Dr. John Ducas, Dr. Malek Kass, Dr. Basem Elbarouni, Dr. Amir Ravandi, Dr. Olga Toleva, Dr Minh Vo
Primary Objective:
To evaluate the overall natural history of NA-SCAD:
a) The overall in-hospital and long-term cardiovascular outcomes with NA-SCAD
b) The prevalence and effects of predisposing arteriopathies on in-hospital and long-term CV outcomes
c) The prevalence and impact of precipitating stressors on in-hospital and long-term CV events

Inclusion Criteria:
I. Patients admitted with ACS (STEMI, NSTEMI or unstable angina)
II. Documented NA-SCAD on coronary angiogram (including diagnosis with OCT or IVUS)
III. The subject must be >/= 18 years of age and able to comply with the study follow-up
Exclusion Criteria:
I. Patients where SCAD is attributed to atherosclerotic coronary artery disease (confirmed by angiographic core-lab)

Dolores Friesen - Research Nurse - Office #1322 or Pager 204-931-2385