study of stem cell therapy in patients with a heart attack
- Conditions
- Health Condition 1: null- Recent MI and occluded infarct related arteries supplying a large myocardial territory
- Registration Number
- CTRI/2013/04/003536
- Lead Sponsor
- Indian Council Of Medical Research New Delhi India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion criteria
1. Recent MI (3-28 d)
2. Obstructed artery needing intervention
3. consent for stem cell therapy
Exclusion criteria
1. Left main disease or TVD needing surgery
2. Hypotension
3. Consent not given
. Patients with significant proximal 3-vessel or left main disease are excluded regardless of functional test results.
2. Patients with post-MI rest angina are not eligible
3. Age <18 yrs
4. Clinical indication for revascularization
5. Serious illness such as cancer or pulmonary disease that limits
3-year survival
6. Severe renal disease defined as serum creatinine ≥3.0 mg/dL
that markedly increases risk of radiographic contrast
7. Severe valvular disease
8. History of anaphylaxis to radiographic contrast
9. Infarct artery too small (reference segment diameter <2.5 mm),
target segment within or beyond extreme tortuosity (>90º angulation),
or otherwise technically a poor candidate for PCI
10 Chronic occlusion of IRA (seen on angiogram obtained before
index MI or angiographic evidence of chronicity, eg, presence
of bridging collaterals)
11. NYHA classes III-IV CHF; patients may be treated for acute
heart failure complicating MI and rescreened
12. Cardiogenic shock or sustained hypotension: systolic BP ≤90 mm Hg
or cardiac index ≤2.2 L/min per m2
13. LV aneurysm in the same location as index MI and present before
index MI
14. Inability to cooperate with the protocol
15. Patient refusal or inability to give informed consent
16. Refusal of patient?s physician to allow patient to participate
17. Pregnancy
18. Contraindication to anticoagulation during PCI or to routine
antiplatelet therapy after stent implantation
19. Qualifying IRA that has been grafted previously; patients with
prior CABG may be enrolled if the IRA was not previously grafted. Dilated or hypertrophic cardiomyopathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method