Trial Outcomes & Findings for Cardiogenesis Transmyocardial Revascularization Registry (NCT NCT01827319)

NCT ID: NCT01827319

Last Updated: 2016-08-15

Results Overview

Number of Participant Deaths

• Recruitment status: COMPLETED
• Target enrollment: 203 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2016-08-15

Participant Flow

Participant milestones

Measure	Received TMR and Enrolled in ANGINA RELIEF Registry
Overall Study STARTED	203
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Received TMR and Enrolled in ANGINA RELIEF Registry
Overall Study Lost to Follow-up	3

Baseline Characteristics

Cardiogenesis Transmyocardial Revascularization Registry

Baseline characteristics by cohort

Measure	Received TMR and Enrolled in ANGINA RELIEF Registry n=203 Participants
Age, Continuous	64.3 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment United States	203 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of Participant Deaths

Outcome measures

Measure	Received TMR and Enrolled in ANGINA RELIEF Registry n=200 Participants
All Cause Mortality	1 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Received TMR and Enrolled in ANGINA RELIEF Registry n=200 Participants
Major Adverse Cardiovascular Events (MACE) Rate, Defined as the Incidence of Cardiac-related Death, Myocardial Infarction (Q-wave and Non Q-wave), Congestive Heart Failure, Cerebrovascular Accident, and Serious Arrhythmia	19 participants

SECONDARY outcome

Timeframe: 30 days

Canadian Cardiovascular Society (CCS) Angina Class-Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.

Outcome measures

Measure	Received TMR and Enrolled in ANGINA RELIEF Registry n=185 Participants
2 CCS Angina Class Reduction	183 participants

Adverse Events

Received TMR and Enrolled in ANGINA RELIEF Registry

Serious events: 19 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Received TMR and Enrolled in ANGINA RELIEF Registry n=200 participants at risk
Cardiac disorders Major Adverse Cardiac Event	9.5% 19/200 • Number of events 25

Other adverse events

Adverse event data not reported

Additional Information

Scott Capps

CryoLife, Inc.

Phone: 800-438-8285

Email: brown.carolyn@cryolife.com

Results disclosure agreements

• Principal investigator is a sponsor employee Additionally, Sponsor has the right to request removal of any confidential information prior to publication.
• Publication restrictions are in place

Restriction type: OTHER