PMS - Catheterization study

Phase 4

Completed

• Conditions: Health Condition 1: null- Mechanical Left Ventricular Unloading with Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction?CRISP AMI

• Registration Number: CTRI/2010/091/000527
• Lead Sponsor: MaquetDatascope Corpn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1. Able to understand and sign an ICF .

2. Greater than or equal to 18 and less than or equal to 90 years of age.

3. General good health, in the opinion of the investigator.

4. ST elevation of greater than or equal to 2mm in 2 contiguous anterior leads or greater than or equal to 4mm total in anterior leads.

5. Scheduled for PCI less than 6 hours from onset of symptoms of anterior MI.

Exclusion Criteria

1. Known contraindication to MRI.

2. Prior thrombolytic therpy during the index event..

3. known history of MI 4. Prior coronary artery bypass graft surgery.

5. known severe aortic insufficiency.

6. Known aortic aneurysm.

7. Known severe calcific aorta-iliac disease or peripheral vascular disease.

8. Experiencing cardiogenic shock

9. Known end-stage renal disease (ESRD), nearing renal replacement, or with CKD stage 4-5 (creatinine clearance 30ml/min/1.73m2)

10. Weight greater than 4001bs. or height less than 4 ft.

11. Women of child bearing potential

12. Current participation in an investigational study using a drug or device.

Study & Design

• Study Type: PMS
• Study Design: Not specified