MedPath

study of stem cell therapy in patients with a heart attack

Phase 2
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

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

Exclusion Criteria

. 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 &#8805;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 &#8804;90 mm Hg
or cardiac index &#8804;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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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